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Adult Onset Still's Disease clinical trials

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NCT ID: NCT01033656 Completed - Clinical trials for Adult-Onset Still's Disease

Treatment of Refractory Adult-onset Still's Disease With Anakinra: a Randomized Study

NordicAOSD05
Start date: December 2005
Phase: Phase 2
Study type: Interventional

An open, randomized, parallel-group, comparative, multicentre study. Patients on corticosteroids (plus conventional therapy) will be randomized to receive anakinra (Kineret®), or one of the following: methotrexate, azathioprine, leflunomide, cyclosporin A or sulphasalazine. Patients enter the study if considered refractory to corticosteroids (prednisolone equivalent ≥10 mg/day) at the time of randomization. The randomized phase of the study will be followed by an open-label extension (OLE) phase, to follow-up drug survival, efficacy, tolerability and disease-related parameters of long-term treatment with anakinra or one of the study DMARDs or a combination of study drugs for additional 28 weeks.